Fluid seal for endoscope

ABSTRACT

A seal is provided for effectively inhibiting the egress of fluids from the working channel of an endoscope when an elongate device having a region with a non-circular cross-sectional shape is disposed therein. The seal has a body portion with a proximal end adapted for insertion of the elongate device, a distal end adapted for connection to the proximal end of the endoscope, and a wall defining a lumen adapted to receive the elongate device and to provide access to the working channel of the endoscope. The seal includes a sealing element for sealing the region of the elongate device with a non-circular cross-sectional shape. The sealing element conforms to the profile of the non-circular region.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of co-pending U.S. Ser. No.10/447,440, filed May 28, 2003; which is a continuation of U.S. Ser. No.09/573,035, filed May 17, 2000, now U.S. Pat. No. 6,663,598; thedisclosures of which are incorporated herein by reference.

FIELD OF THE INVENTION

The present invention general relates to endoscopic systems andprocedures. More specifically, the present invention relates to sealsfor use in combination with an endoscope, sometimes referred to asendoscope seals or biopsy seals.

BACKGROUND OF THE INVENTION

Endoscopic procedures for treating abnormal pathologies within thealimentary canal system and biliary tree (including the biliary,hepatic, and pancreatic ducts) are increasing in number. The endoscopeprovides access to the general area of a desired duct using directvisualization. However, the duct itself must be navigated using acatheter in conjunction with a guidewire under fluoroscopy. A widevariety of catheters are known for treatment of such targeted anatomicalregions. Examples of biliary catheters are disclosed in U.S. Pat. No.5,397,302 to Weaver et al., U.S. Pat. No. 5,320,602 to Karpiel and U.S.Pat. No. 5,921,971 to Argo et al., the disclosures of which are herebyincorporated by reference.

Argo et al. '971 discloses a catheter for use in biliary procedures,wherein the catheter includes a shaft having a proximal end and a distalend. A guidewire lumen extends through the shaft from a proximalguidewire port located proximal of the distal end of the shaft, to adistal guidewire port located at the distal end of the shaft. The shaftmay also include a slot or channel extending from a proximal end of theshaft to the proximal guidewire port. By utilizing a slot or channel,the proximal shaft portion has a non-circular profile or cross-sectionas best seen in FIGS. 5A and 6A of Argo et al. '971. Cathetersincorporating such a guidewire opening and channel are often referred toas rapid exchange or single operator exchange type biliary catheters.One drawback with such rapid exchange or single operator exchangebiliary catheters is the inability or relative difficulty in sealingaround the non-circular shaft, such that fluid (bile liquid and air) mayleak out of the working channel of the endoscope around the non-circularshaft of the biliary catheter.

Conventional endoscope seals are adapted to seal about catheters havingcircular shafts, and generally do not effectively seal about cathetershaving non-circular shafts. Such conventional seals are commerciallyavailable from Olympus, Fuji and Pentax. An example of a prior artendoscope seal is disclosed in U.S. Pat. No. 4,920,953 to McGown. Theendoscope seals commercially available and the endoscope seal disclosedin McGown '953 generally include a body portion having a proximal endadapted to receive an elongate device such as a biliary catheter, adistal end adapted for connection to the proximal end of the endoscope,a lumen extending through the body portion, and a membrane disposed inthe lumen, wherein the membrane includes a small circular hole oraperture. The circular aperture is sized to closely fit the elongatedevice inserted therein such that fluids (bile and air) do not readilyescape from the working channel of the endoscope.

However, it can be readily appreciated that when a biliary catheter orother elongate device having a shaft with a non-circular cross sectionis placed through the circular aperture, at least a portion of theaperture does not engage the non-circular shaft. Accordingly, such priorart endoscope seals do not effectively inhibit the egress of bileliquids and air exiting the working channel of the endoscope when anelongate device having a non-circular cross-section is utilized. Becauserapid exchange catheters are becoming more prevalent, and because suchrapid exchange catheters have a non-circular shaft cross-section, thereis a significant demand for an endoscope seal that effectively seals orinhibits the egress of fluid from the working channel of an endoscope,when a device having a non-circular shaft cross-section is usedtherewith.

SUMMARY OF THE INVENTION

The present invention satisfies this demand by providing an endoscopeseal that effectively inhibits the egress of fluid from the workingchannel of an endoscope when an elongate device, such as a rapidexchange biliary catheter, having a non-circular shaft is disposedtherein. The seal of the present invention is also suitable for othercatheters having non-circular shafts such as rapid exchange vascularcatheters. In addition, some embodiments of the present invention areperfectly suitable for sealing about elongate devices having shafts witha circular profile. Accordingly, the endoscope seals of the presentinvention are both versatile and functional, because they effectivelyinhibit, or at least reduce, the egress of fluids (bile and air) fromthe working channel of the endoscope when an elongate device having acircular or non-circular shaft is utilized.

The endoscope seals of the present invention include a body portionhaving a proximal end adapted for insertion of an elongate device suchas a rapid exchange type catheter, a distal end adapted for connectionto the proximal end of an endoscope, a lumen extending therethroughwhich is adapted to receive the elongate device and to provide access tothe working channel of the endoscope, and a means for conforming to thenon-circular shaft of the elongate device to inhibit the flow of fluidfrom the working channel of the endoscope.

In a first embodiment, the conforming means may comprise a protrusionextending radially inward in the lumen of the body portion. Theprotrusion may comprise a geometry that mates with the non-circularshaft of the elongate device. In a second embodiment, the conformingmeans may comprise a plurality of protrusions extending radially inwardin the lumen body portion. The plurality of protrusions may be uniformlyspaced about the circumference of the lumen and may have sufficientflexibility to conform to a non-circular geometry. In a thirdembodiment, the conforming means may comprise a sealing material such asa surgical foam that is disposed in the lumen of the body portion orinjected therein just prior to use. In a fourth embodiment, theconforming means may comprise a sealing mandrel that it is disposed inthe lumen of the body portion. The sealing mandrel conforms to thenon-circular geometry to define a collective circular geometry that isreadily sealed by a conventional circular aperture in the body portion.Whether a single protrusion, a plurality of protrusions, a sealingmaterial or a sealing mandrel, the present invention provides endoscopeseals that readily seal about an elongate devices having either circularor non-circular profiles.

The present invention also provides a variable diameter main bodyportion and a compression mechanism. The variable diameter main bodyportion may incorporate a conventional membrane with a circular apertureor may incorporate any of the conforming means described above. Thecompression mechanism may be used to tighten the variable diameter bodyportion to compress the membrane therein around a non-circular shaft toestablish a fluid seal.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a side view of the endoscope seal of the present invention;

FIG. 1B is a top view of the endoscope seal shown in FIG. 1A;

FIG. 2A is a top view of a body portion of an endoscope seal utilizing aplurality of protrusions;

FIG. 2B is a cross-sectional view taken along line 2B-2B in FIG. 2A;

FIG. 3A is a top view of a body portion of an endoscope seal utilizing asingle protrusion;

FIG. 3B is a cross-sectional view taken along line 3B-3B in FIG. 3A;

FIG. 4A is top view of a body portion of an endoscope seal utilizing asealing material;

FIG. 4B is a cross-sectional view taken along line 4B-4B in FIG. 4A;

FIG. 5A is a top view of a body portion of an endoscope seal utilizingan injected sealing material;

FIG. 5B is a cross-sectional view taken along line 5B-5B in FIG. 5A(FIG. 5B also illustrates an injection apparatus);

FIG. 6A is an isometric view of a tightening ratchet for use incombination with a variable diameter valve;

FIG. 6B is a top view of the tightening ratchet illustrated in FIG. 6A;

FIG. 6C is an isometric view of the tightening ratchet illustrated inFIG. 6A disposed about a variable diameter main body portion;

FIG. 6D is a cross-sectional view of the tightening ratchet disclosedabout the variable diameter main body portion as illustrated in FIG. 6C;

FIG. 7A is a top view of a body portion of an endoscope seal utilizing asealing mandrel;

FIG. 7B is a cross-sectional view taken along line 7B-7B in FIG. 7A; and

FIG. 7C is a cross-sectional view of the sealing mandrel illustrated inFIGS. 7A and 7B.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The following detailed description should be read with reference to thedrawings in which similar elements and different drawings are numberedthe same. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

Refer now to FIG. 1A which illustrates a side view of an endoscope sealin accordance with the present invention. Endoscope seal 10 includes amain body portion 100, a plug portion 20 and an adapter ring portion 30.The details of main body portion 100 are discussed in more detail withreference to FIGS. 2A and 2B. Main body portions 200, 300, 400, and 500as discussed in detail with reference FIGS. 3A-3B, FIGS. 4A-4B, FIGS.5A-5B, and FIG. 6D, respectively, may be used in place of main bodyportion 100.

Main body portion 100 includes a body 112 having a proximal end and adistal end. An outwardly extending flange 114 is connected to the distalend of the body 112. An inwardly extending flange 116 is connected tothe proximal end of the body 112. As best seen in FIG. 1B, a centrallumen 120 extends through body 112, and a seal 140 is disposed in thelumen 120. Central lumen 120 is sized to accommodate the shaft ofelongate device such as a biliary catheter (not shown).

The plug portion 20 is connected to the main body portion 100 by aflexible arm 22. The plug portion 20 includes a cap 24, a middle portion26, and a flange 28. The flexible arm 22 allows the plug portion 20 tobe inserted into the proximal end of the main body portion 100 and sealthe central lumen 120 in the absence of any devices inserted therein.

The adapter ring portion 30 is connected to the main body portion 100 bya flexible arm 32. The adapter ring portion 30 includes an inwardlyextending top flange 36 and an inwardly extending bottom flange 38 whichtogether define a recess 37 within the ring 30. Adapter ring portion 30also defines a central lumen 34. The flexible arm 32 permits the adapterring portion 30 to be placed around the flange 114 of the main bodyportion 100. The adapter ring portion 30 permits the endoscope seal 10to be connected to an endoscope having a larger diameter proximal end aswill be discussed in more detail hereinafter.

Refer now to FIGS. 2A and 2B which illustrate the features of main bodyportion 100 in greater detail. Central lumen 120 includes a proximalport 121, an upper cavity 122, a middle cavity 124, a lower cavity 126,and a distal port 127. The proximal port 121 has an inside diameterslightly less than the outside diameter of the flange 28 of the plugportion 20. The upper cavity 122 is sized to accommodate the flange 28of the plug portion 20. With this arrangement, the flange 28 may besnapped through the proximal port 121 into the upper cavity 122 suchthat the plug portion 20 effectively seals the central lumen 120 when nodevices are present therein.

Distal port 127 is sized to be slightly smaller than the diameter of theproximal end of the endoscope. The lower cavity 126 is sized toaccommodate the flange of the proximal end of the endoscope (not shown).Within the arrangement, the proximal end of the endoscope may be snappedinto the distal port 127 to connect the endoscope seal 10 to theendoscope and to establish fluid communication between the central lumen120 and the working channel of the endoscope.

If the proximal end of the endoscope is too large for the lower cavity126 and distal port 127, the adapter ring portion 30 may be placed onthe flange 114. Specifically, the lumen 34 of the adapter ring portion30 has a diameter that is slightly less than the outside diameter of theflange 114. The recess 37 between the upper flange 36 and lower lange 38of the adapter ring portion 30 is sized to accommodate the flange 114leaving sufficient space to accommodate the proximal flange of theendoscope. With this arrangement, the adapter ring portion 30 may besnapped into place around the flange 114 and the proximal flange of theendoscope (not shown) may be snapped into the recess 37 of the adapterring portion 30. Thus, the adapter ring portion 30 in combination withthe flange 114 permits the endoscope seal 10 to fit endoscopes ofdifferent sizes.

With this arrangement, the distal end of the main body portion 100 maybe connected to the proximal end of the endoscope (not shown). When themain body portion 100 is connected to the endoscope, the central lumen120 is aligned with and in fluid communication with the working channelof the endoscope. The central lumen 120 is sized and adapted forinsertion of an elongate device such as a biliary catheter. Thus, anelongate device may be inserted into the proximal end of the main bodyportion 100, through the lumen 120, and into the working channel of theendoscope.

The middle cavity 124 of the central lumen 120 is defined by the sealmechanism 140. Middle cavity 124 is conically shaped to facilitate easyinsertion of an elongate device therein. The conically shaped cavity 124tapers from a proximal aperture 142 to a distal aperture 144. Aplurality of inwardly projecting protrusions 146 extend from theproximal aperture 142 to the distal aperture 144. Although eightprotrusions 146 are illustrated, it is contemplated that virtually anymember of protrusions 146 may be utilized. Protrusion 146 is uniformlyspaced about the wall 148 defining the lumen 124. The protrusions 146are sufficiently flexible to conform to a non-circular shaft of anelongate device inserted therein.

For example, if the non-circular shaft illustrated in FIGS. 5A and 6A ofArgo et al. '971 was inserted into the seal mechanism 140, one or moreof the protrusions 146 would be disposed in the non-circular portion(i.e., the C-shaped channel) of the shaft, thereby effectively sealingabout the non-circular shaft. Although the protrusions 146 may notprovide a fluid-tight seal about a non-circular shaft, it is believedthat any decrease in the amount of fluid (bile and air) escaping fromthe working channel of the endoscope is a significant improvement.Accordingly, as used herein, the term seal may refer to a fluid-tightseal or a seal which significantly inhibits the egress of fluid. Theentire endoscope seal 10 may be made of conventional materials usingconventional techniques. For example, the endoscope seal 10 may beformed by injection molding a flexible medical grade silicone. From thefunctional description provided herein, those skilled in the art willreadily appreciate that the endoscope seal 10 may be formed from a widevariety of suitable flexible materials such as rubber, silicon orelastomer. In addition, the endoscope seal 10 may be made by a varietyof different manufacturing methods, but injection molding is preferred.

The endoscope seal 10 may have an overall length on the order of 3.670inches. The flexible arms 22 and 32 may have a thickness on the order of0.085 inches and a width on the order of 0.20 inches. The plug portion20 may have a thickness of approximately 0.255 inches and an outsidediameter of approximately 0.560 inches. The flange 28 of the plug 20 mayhave an outside diameter of approximately 0.400 inches and a thicknessof approximately 0.085 inches. The middle portion 26 of the plug 20 mayhave a diameter of approximately 0.320 inches and a thickness ofapproximately 0.085 inches.

The adapter ring portion 30 may have an outside diameter portion ofapproximately 0.780 inches, an inside diameter of approximately 0.500inches, and a thickness of approximately 0.260 inches. The top flange 36and the bottom flange 38 of the adaptor ring portion 30 may have athickness of approximately 0.065 inches, and the recess 37 may beapproximately 0.040 inches deep.

The main body portion 100 may have an overall height of approximately0.550 inches. The body 112 may have a diameter of approximately 0.560inches and a height of approximately 0.480 inches. The flange 114 mayhave an outside diameter of approximately 0.680 inches and a thicknessof approximately 0.70 inches. The proximal port 121 may have an insidediameter tapering from approximately 0.400 inches to an approximately0.320 inches. Similarly, the distal port 127 may have an inside diametertapering from approximately 0.280 inches to approximately 0.200 inches.The upper cavity 122 may have a diameter of 0.400 inches and a height ofapproximately 0.110 inches. The lower cavity 126 may have a diameter ofapproximately 0.350 inches and a height of approximately 0.130 inches.The middle cavity 124 may have an inside diameter tapering fromapproximately 0.170 inches to approximately 0.040 inches. The individualprotrusions 146 may be tapered from the proximal aperture 142 to thedistal aperture 144, having a width of approximately 0.020 inchestapering to approximately 0.015 inches. The protrusions 146 may beseparated by slots, each having a width tapering from approximately0.023 inches to approximately 0.003 inches.

Those skilled in the art will recognize that the endoscope seal 10 mayhave dimensions different than the above dimensions, which are providedfor purposes of illustration only.

Refer now FIGS. 3A and 3B which illustrate body portion 200 inaccordance with an alternative embodiment of the present invention. Asmentioned previously, body portion 200 may be used in place of bodyportion 100 as described with reference to FIGS. 1A, 1B, 2A, and 2B.Except as described hereinafter and except as shown in the drawings,body portion 200 is the same in design and function as body portion 100.

Main body portion 200 includes a seal mechanism 240. Seal mechanism 240includes a single protrusion 246 extending radially inward. Protrusion246 extends from a proximal aperture 242 to a distal aperture 244.Protrusion 246 may have a wide variety of geometries, but preferably hasa geometry that mates with the non-circular portion of the shaft of theelongate device inserted into the central lumen 120. For example, if thenon-circular shaft illustrated in FIGS. 5A and 6A of Argo et al '971were disposed in the central lumen 120, the single protrusion 246 wouldpreferably have a geometry conforming to the slot of the C-shapedchannel. Those skilled in the art will recognize that other non-circularshafts may be utilized and that the protrusion 246 may be modified tomate with the non-circular portion thereof.

Because the single protrusions 246 will limit rotation of the elongatedevice inserted through the central lumen 120, it may desirable topermit rotation of the main body portion 200. This may be accomplished,for example, by providing a low-friction connection between the distalend of the main body portion 200 and the proximal end of the endoscope.A low-friction connection may be accomplished by a variety of means,such as by utilizing low-friction materials and lubricants.

Refer now to FIGS. 4A and 4B which illustrate main body portion 300 inaccordance with yet another embodiment of the present invention. Asmentioned previously, main body portion 300 may be used in place of mainboy portion 100 described with reference to FIGS. 1A, 1B, 2A, and 2B.Except as described hereinafter and except illustrated in the drawings,main body portion 300 is the same in design and function as main bodyportion 100. In this particular embodiment, main body portion 300utilizes includes a seal 140 comprising a material havingcharacteristics of easy penetration high-fluid absorption, and tearresistance, such as a surgical foam to seal about the non-circularshaft. Sealing material 340 is disposed in the upper cavity 122, and toaccommodate the sealing material 340, the height of the upper cavity 122is increased at the expense of the height of the middle cavity 124.Although not shown, a liquid drainage line and reservoir may beconnected to the upper cavity 122 to drain excess fluid (bile and air)therefrom.

The sealing material 340 may comprise virtually any suitable medicalgrade material that has easy penetration, high-fluid absorption, andtear resistance characteristics. Preferably, the sealing materialcomprises a closed-cell medium density surgical foam commerciallyavailable from Rynel of Maine. When a non-circular shaft of an elongatedevice is inserted through the sealing material 340, the sealingmaterial 340 tends to create a passage conforming to the profile of thenon-circular shaft, thereby effective sealing about the non-circularshaft.

The sealing material 340 may be relatively liquid or relatively solid.For example, the sealing material 340 may be relatively solid such thatit is suitable for molding into a wide variety of desired shapes. Thesealing material 340 may be molded to fit in the upper cavity 122 and tohave a pilot hole extending therethrough. Whether the sealing material340 is in the form of a liquid or solid, the plug portion 20 may beutilized to keep the sealing material 340 contained in the upper cavity122 prior to use.

The sealing material may alternatively comprise fibrous materials thatare very compliant and fluid absorbent such as cotton or syntheticfabrics. Alternatively, the sealing material 340 may comprise a gel-likematerial to develop a very lubricious and compliant seal. The sealingmaterial 340 may be cold-molded or insert-molded and a lubricant may beadded to the sealing material to reduce friction and increase fluidabsorption.

Refer now to FIGS. 5A and 5B, which illustrate main body portion 400 inaccordance with yet another alternative embodiment of the presentinvention. Except as described hereinafter and except as illustrated inthe drawings, main body portion 400 is the same in design and functionas main body portion 300 described in reference to FIGS. 4A and 4B. Mainbody portion 400 includes an injectable sealing material 440 that may beinjected into the upper cavity 122 just prior to use. To facilitate suchinjection, the body 112 may be provided with a thin-walled section 412.A suitable injection device such as a syringe 450 may be used to piercethe thin-walled portion 412 and inject the liquid sealing material 440.Sealing material 440 may be injected into the upper cavity 122 with theplug portion 20 inserted into the proximal end of the main body portion400 to contain the sealing material 440 in the upper cavity 122 prior touse. Sealing material 440 has the same properties and performs the samefunction as sealing material 340 described with reference to FIGS. 4Aand 4B, except sealing material 440 has a lower initial viscosity.

Refer now to FIGS. 6A, 6B, 6C, and 6D which illustrate a variablediameter main body portion 500 and tightening ratchet 600 for usetherewith. Except as described herein and except as shown in thedrawings, variable diameter body main portion 500 is the same in designand function as main body portion 100 described with reference to FIGS.1A, 1B, 2A, and 2B. The body 512 includes a central waist portion 514that facilitates compression of the lumen 124 at relatively low forcesdue to the reduced diameter of the waist 514. However, it iscontemplated that the compressive forces of the tightening ratchet 600may be used with or without the reduced diameter waist portion 514. Inparticular, the tightening ratchet 600 may be used with a constantdiameter body 512. By actuating tightening ratchet 600 disposed aboutthe variable diameter main body portion 500 as illustrated in FIGS. 6Cand 6D, the central cavity 124 reduces in diameter and seals about thenon-circular shaft of the elongate device extending therethrough.

Tightening ratchet 600 includes a hoop 610 that may vary in diameter byvirtue of the sliding ends 612 and 614. Note that if a reduced diameterwaist portion 514 is provided on the variable diameter main body portion500, the hoop 610 may include a conforming geometry as illustrated inFIG. 6D. Tightening ratchet 600 further includes a plurality of teeth622 that engage a lever arm 630 to lock the moving ends 612 and 614 ofthe hoop 610 as the diameter of the hoop 610 is decreased. The teeth 622are disposed on a flexible arm 620 that is normally biased against thelever arm 630 but may be deflected to permit the teeth 622 to disengagethe lever arm 630, thereby permitting the ends 612 and 614 of the loop610 to move and thereby increase the diameter of the hoop 610. Both theflexible arm 620 and the lever arm 630 may include gripping surfaces 624and 632, respectively, to facilitate easy gripping of the tighteningratchet 600. Those skilled in the art will recognize that there are manyalternative compression mechanisms to tightening ratchet 600, such as ascrew-type compression clamp, a spring compression clamp, etc.

Refer now to FIGS. 7A, 7B and 7C which illustrate main body portion 700in accordance with another embodiment of the present invention. Exceptas described herein and except as illustrated in the drawings, main bodyportion 700 is the same in design and function as main body portion 200described with reference to FIGS. 3A and 3B. Main body portion 700includes a seal mechanism 740. Seal mechanism 740 includes a sealingmandrel 746 extending through the central lumen 120. Sealing mandrel 746may have a wide variety of cross-sectional geometries, but preferablyhas a geometry that mates with the non-circular portion of the shaft ofthe elongate device inserted into the central lumen 120. For example, ifthe non-circular shaft illustrated in FIGS. 5A and 6A or Argo et al.'971 were disclosed in the central lumen 120, the sealing mandrel 746would preferably have a geometry conforming to the slot of this C-shapedchannel, as best seen in FIG. 7C. The entire length of the sealingmandrel 746 may have a conforming geometry or only the portion of thesealing mandrel 746 extending from the proximal aperture 742 to thedistal aperture 744 may have a conforming geometry while the remainderof the sealing mandrel 746 has a different cross-sectional geometry,such as a circular cross-section. Those skilled in the art willrecognize that other non-circular shafts may be utilized and that thesealing mandrel 746 may be modified to have a cross-sectional geometrythat mates with the non-circular portion thereof. Thus, with the sealingmandrel 746 disposed in the slot of the biliary catheter (such asbiliary catheter disclosed in Argo et al. '971), the collectivecross-sectional profile is essentially circular such that the circularaperture 744 is able to establish a fluid tight seal.

Those skilled in the art will recognize that the present invention maybe manifested in a variety of forms other than the specific embodimentsdescribed and contemplated herein. Accordingly, departures in form anddetail may be made without departing from the scope and spirit of thepresent invention as described in the appended claims.

1. A seal for use in combination with an elongate device and anendoscope, the elongate device having a region with a non-circularcross-sectional shape, the endoscope having a proximal end and a workingchannel extending therethrough, the seal comprising: a body portionhaving a proximal end adapted for insertion of the elongate device, adistal end adapted for connection to the proximal end of the endoscope,and a wall defining a lumen extending therethrough adapted to receivethe elongate device and to provide access to the working channel of theendoscope; and a sealing element for sealing the region having anon-circular cross-sectional shape disposed in the lumen of the bodyportion, wherein the sealing element generally conforms to the profileof the non-circular region.
 2. The seal of claim 1, wherein the sealingelement includes at least one protrusion disposed in the lumen of thebody portion, the protrusion extending radially inward from the wall tosealingly engage the region with a non-circular cross-sectional shape.3. The seal of claim 1, wherein the region with a non-circularcross-sectional shape is defined by an axial slot in the elongatedevice.
 4. The seal of claim 1, wherein the region with a non-circularcross-sectional shape is defined by a C-shaped channel in the elongatedevice.
 5. The seal of claim 1, wherein the elongate device is arapid-exchange type catheter.
 6. The seal of claim 1, further comprisinga flexible arm attached to the body portion.
 7. The seal of claim 6,further comprising a plug attached to the flexible arm, the plug beingconfigured to seal the proximal end of the body portion.
 8. The seal ofclaim 6, further comprising an adaptor ring attached to the flexiblearm, the adaptor ring being configured for connection to the distal endof the body portion.
 9. The seal of claim 6, further comprising a plugconfigured to seal the proximal end of the body portion attached to theflexible arm, a second flexible arm attached to the body portion, and anadaptor ring configured for connection to the distal end of the bodyportion attached to the second flexible arm.
 10. The seal of claim 1,wherein the sealing element includes a mandrel disposed in the lumen ofthe body portion, the mandrel being configured to mate with the regionhaving a non-circular cross-sectional shape.
 11. The seal of claim 1,wherein the sealing element includes a plurality of protrusions disposedin the lumen of the body portion and extending radially inward from thewall to sealingly engage the region with a non-circular cross-sectionalshape.
 12. The seal of claim 1, wherein the body portion includes athin-walled section and wherein the sealing element includes a sealingmaterial inserted into the lumen of the body portion through thethin-walled section.
 13. The seal of claim 1, wherein the sealingelement is a sealing material including compliant, fluid absorbingfibers.
 14. The seal of claim 1, wherein the sealing element is asurgical foam.
 15. The seal of claim 1, for use with a compressionmechanism, wherein the sealing element includes a variable diameter bodyportion wall defining a variable diameter lumen adapted to receive thenon-circular region of the elongate device; wherein the compressionmechanism fits around the body portion and compresses the body portion,thereby reducing the diameter of the wall such that the lumen conformsto the non-circular region of the elongate device.
 16. The seal of claim15, wherein the body portion has a reduced diameter waist portion.
 17. Aseal for use with one or more medical devices, comprising: a main bodyhaving a lower cavity, a distal port adjacent the lower cavity, a middlecavity, an upper cavity, a proximal port adjacent the upper cavity, anda central lumen extending therethrough; wherein the distal port isconfigured for securing the body to an endoscope; and one or moreprotrusions disposed in the middle cavity, the protrusions beingconfigured to sealingly engage a non-circular region of a medical deviceextending through the central lumen.
 18. The seal of claim 17, whereinthe endoscope includes a proximal end having one or more flanges andwherein the seal is connectable to the endoscope by disposing the one ormore flanges in the lower cavity.
 19. The seal of claim 17, furthercomprising a plug having one or more flanges, the plug being connectableto the seal by disposing the one or more flanges in the upper cavity.20. The seal of claim 17, wherein the non-circular region of the medicaldevice is defined by an axial slot in the medical device.
 21. The sealof claim 17, wherein the non-circular region of the medical device isdefined by a C-shaped channel in the medical device.
 22. A seal for usewith one or more medical devices, comprising: a main body having a lowercavity, a distal port adjacent the lower cavity, a middle cavity, anupper cavity, a proximal port adjacent the upper cavity, and a centrallumen extending therethrough; wherein the distal port is configured forsecuring the body to an endoscope; and a sealing element disposed in themiddle cavity, the sealing element being configured to sealingly engagea non-circular region of a medical device extending through the centrallumen.